BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS

    MDR report key: 19318904 · Received May 15, 2024

    Report

    Report Number
    1038671-2024-01254
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    April 29, 2024
    Report Date
    February 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207043
    PMA / PMN Number
    K121392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 4789622 188-01-07 - WEDGE PLASMA X/O SZ 7. 4859112 186-01-56 - INTEGRIP CC, CLUSTER 56MM,G3 . 4893051 170-40-03 - BIOLOX DELTA FEMORAL HEAD 40MM 0D, +3.5MM 4912710 180-65-30 - ALTEON 6.5MM SCREW, 30MM.

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THE PATIENT MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR AND/OR OSTEOLYSIS: IMPLANTED WITH A LATERALIZED LINER, COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER WAS USED AND IMPLANTED WITH A COMPONENT HAVING A SHELF AGE OF GREATER THAN 2 YEARS. THE MOST LIKELY CAUSE FOR THE REPORTED REVISION DUE TO PROSTHESIS WEAR AND OSTEOLYSIS MAY HAVE BEEN A COMBINATION OF RISK FACTORS SUCH AS USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS (FITNESS FOR SURGERY, BIOMECHANICS, ACTIVITY LEVEL AND LOCAL TISSUE OXIDATION POTENTIAL). HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 6 YEARS 9 MONTHS POST THE INITIAL THA, THE PATIENT WAS REVISED DUE TO SEVERE OSTEOLYSIS AND POLY WEAR. THE POLY WAS IN SEVERAL PIECES. NO ISSUES WITH SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357633 NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862207043

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10.